Warning Letter Trends for the First Half of FY2016

December 13, 2016

We provide an update on drug GMP warning letters issued halfway through the FDA fiscal year and how they compare to previous years. We categorize the warning letters as those issued to compounding pharmacies / outsourcing facilities, those issued to pharma and API sites in the US and those issued to sites outside the US. A review of this timeframe for a limited set of warning letters issued in 2015 suggested that the time interval was increasing. Here we provide a full data set, both domestic and OUS, to support the conclusion regarding the increase in this time interval over the past 3 ½ fiscal FDA years…READ MORE

Get a Free Sample of Warning Letter Deficiencies "Data Integrity", newly published BLOG items and updates on additions to our store.